Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05282251

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Thoracic surgery is now common and as other surgeries evolution of minimally invasive techniques is employed. Video-assisted thoracic surgery (VATS) produces little scar but may produce severe pain that may affect the pulmonary function. Many procedure was developed like intercostal nerve block which require injections at multiple levels, Insertion of local anaesthetic (LA) in the surgical drain but that was dangerous due to the large amount of LA and not sufficient to completely eliminate pain. Bupvicaine nebulization, through surgical port which won't make any other wound, thought to be sufficient because Nebulization will enable us better distribution and less amounts of LA. Bupvicaine is local anaesthetic amide group that works by blocking sodium channels thus preventing progression of action potential.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases	Drug: Bupivacain	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Pain Managment After VATS to Reduce Postoperative Pain and Improve Pulmonary Function

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pain managment after VATS	Drug: Bupivacain Intrapleural Nebulization of local anaesthetic

Arm

Intervention/Treatment

Experimental: Pain managment after VATS

Drug: Bupivacain

Intrapleural Nebulization of local anaesthetic

Outcome Measures

Primary Outcome Measures

Numeric pain scale [24 hours]
Decrease pain assessed by Numeric pain scal

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age: > 18 years
Patients that reach American socity of anesthesiologist class 1-111
Scheduled for VATS surgery under general anesthesia.

Exclusion Criteria:

● Allergy to local anesthetics
Patient with pleural inflammation due to recent pneumonia
Patients who are unable or unwilling to perform spirometer test
Renal dysfunction: (Elevated creatinine > 2 mg\dl)
Hepatic dysfunction: (Elevated hepatic enzymes three times above normal value)
History of addiction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut	Assuit	Egypt	880

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Essam El-den Moubark Mohammed Hussein, Resident doctor, Assiut University

ClinicalTrials.gov Identifier:

NCT05282251

Other Study ID Numbers:

Pain managment after VATS

First Posted:

Mar 16, 2022

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Mar 16, 2022